Data may be recorded and/or generated by numerous data recording devices. Examples of such devices are computer systems used in clinical trials (e.g., electronic data capture (EDC), safety, or randomization systems), computer systems used by healthcare professionals (e.g., electronic health records (EHR) or electronic medical records (EMR) systems), computer systems used by consumers (e.g., electronic patient-reported outcomes (ePRO) systems), medical devices (e.g., a blood glucose device used in a home, or an ECG in a clinic), consumer devices (e.g., a blood pressure cuff used on a phone, or an activity tracker), and centralized systems for storage of data from devices (e.g., in the cases of activity trackers, which often send their data via the Internet to the “cloud”). Other devices capturing clinical data are used in pre-clinical and post-marketing studies as well.
Currently, these different clinical data recording devices may provide or export data in different formats or via specific types of interchange protocols or standards, such as HL7 (Health Level Seven), CDISC/ODM, and E2B. In the United States, HL7's messaging standard is supported by most major medical information systems vendors. CDISC standards, set by the standards developing organization (SDO) of the same name, are platform-independent data standards used in clinical research. Even with the use of communication standards, clinical data recording devices transmit (export) data or generate their own audit trails, which data may not be standardized and thus may not be usable in combination with that of other devices.
Where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function.